Veterinary Medicines

MACROMUTIN 125 mg/ml Oral Solution for Poultry and Pigs

Authorised
  • Tiamulin hydrogen fumarate
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Product identification

Medicine name:
MACROMUTIN 125 mg/ml Oral Solution for Poultry and Pigs
MACROMUTIN 125 mg/ml SOLUCION ORAL PARA AVES Y PORCINO
Active substance:
  • Tiamulin hydrogen fumarate
Target species:
  • Pig
  • Turkey
  • Chicken (layer hen)
  • Chicken (broiler)
  • Chicken (for reproduction)
Route of administration:
  • In drinking water use

Product details

Active substance and strength:
  • Tiamulin hydrogen fumarate
    12.50
    gram(s)
    /
    100.00
    millilitre(s)
Pharmaceutical form:
  • Solution for use in drinking water
Withdrawal period by route of administration:
  • In drinking water use
    • Pig
      • Meat and offal
        6
        day
    • Turkey
      • Meat and offal
        6
        day
    • Chicken (layer hen)
      • Meat and offal
        6
        day
      • Eggs
        0
        day
    • Chicken (broiler)
      • Meat and offal
        6
        day
    • Chicken (for reproduction)
      • Meat and offal
        6
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01XQ01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Laboratorios Calier S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Calier S.A.
Responsible authority:
  • The Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 1732 ESP
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0123/001
Concerned member states:
  • Portugal

Documents

Summary of Product Characteristics

English (PDF)
Published on: 5/04/2023
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Spanish (PDF)
Published on: 17/03/2023
Download

Package Leaflet

English (PDF)
Published on: 5/04/2023
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Spanish (PDF)
Published on: 17/03/2023
Download

Combined File of all Documents

English (PDF)
Published on: 21/11/2022
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 17/03/2023
Download

es-puar-macromutin-125-mg-ml-oral-solution-for-poultry-and-pigs-es.pdf

Spanish (PDF)
Published on: 17/03/2023
Download
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